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Compares treatment options for Metastatic Castration-resistant Prostate Cancer
Official title A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07365995
What this study is testing
What is BNT324?
BNT324 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as DB-1311.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
- Must have documented progressive prostate cancer based on at least one of the following criteria:
- Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured...
- Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
- Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
You likely can't join if
- Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
- Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis. NOTE: Other...
See the full eligibility criteria
- Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
- Must have documented progressive prostate cancer based on at least one of the following criteria:
- Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to...
- Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
- Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
- Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.
- Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.
- Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Participant being treated with luteinizing...
- Must have an Eastern Cooperative Oncology Group performance score of 0 or 1. Key
- Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
- Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Fort Myers, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Niles, Illinois, United States
- Peoria, Illinois, United States
- Rockville, Maryland, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Tyler, Texas, United States
- Wichita Falls, Texas, United States
- Fairfax, Virginia, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Fort Myers, Florida, United States; St. Petersburg, Florida, United States; West Palm Beach, Florida, United States; Niles, Illinois, United States; Peoria, Illinois, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.